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Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium)

Information source: Italfarmaco
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Cancer; Metastatic Cancer

Intervention: Nadroparin calcium (Drug); saline solution (placebo) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Italfarmaco

Official(s) and/or principal investigator(s):
Giancarlo Agnelli, MD, Study Chair, Affiliation: Internal and Vascular Medicine University of Perigia (Italy)

Summary

In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2: 1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).

Clinical Details

Official title: Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy

Secondary outcome:

Survival, at the end of study treatment

Response to chemotherapy

For patients with central venous catheters (CVC), complications of possible thrombotic origin, such as malfunction or requirement of CVC removal

Superficial thrombophlebitis of lower limbs

Asymptomatic thromboembolic events diagnosed during tests performed for other purposes

Safety (major bleeding, minor bleeding, other adverse events)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

INCLUSION CRITERIA:

- both sexes;aged>18 years;

- suffering from different types of malignancies(lung, breast,gastric,colon-

rectum,pancreatic,ovarian,head and neck cancer)undergoing systemic chemotherapy,

- having signed Informed Consent prior to initiation of any study procedure.

EXCLUSION CRITERIA:

- adjuvant and neo-adjuvant chemotherapy;

- objectively confirmed venous or arterial thromboembolism in the last three months;

- antithrombotic treatment for other indications;

- life expectancy of less than 3 months;

- Performance Status>2(ECOG);

- active bleeding or bleedings in the last four weeks requiring

hospitalization,transfusion or surgical intervention;

- bleeding diathesis(prothrombin time<70% or activated partial thromboplastin time

ratio>1. 3),or platelet count<50x10^9/L;

- cerebrovascular hemorrhage in the last six months;

- known active gastric or duodenal ulcer;

- known cerebral metastasis;

- cerebral aneurysm;

- III-IV grade diabetic retinopathy;

- severe and uncontrolled hypertension(systolic blood pressure>180 mmHg or diastolic

blood pressure>110 mmHg);

- chronic atrial fibrillation;

- acute endocarditis;

- acute pancreatitis;

- known hypersensitivity to unfractionated heparin or LMWH;

- previous occurrence of heparin-induced thrombocytopenia;

- renal impairment (dependent on dialysis or creatinine higher than 2. 5mg%);

- liver insufficiency (alanine aminotransferase,aspartate aminotransferase,alkaline

phosphatase levels>3 times the upper limit of the normal ranges and/or total bilirubin >3. 0 mg/ml);

- pregnancy or childbearing potential without adequate contraception;

- treatment with other investigational drugs or patient inclusion in other clinical

trials;

- patients who are unable to fulfill the study requirements in terms of

visits/compliance to treatment.

Locations and Contacts

Medical Oncology Department Oncology Institute, Bari 70126, Italy

Medical Oncology Unit, Bergamo 24100, Italy

Medical Oncology Department - Bellaria Hospital, Bologna 40139, Italy

Medical Oncology Department - Businco Hospital, Cagliari 09121, Italy

Medical Oncology Department University of Cagliari, Cagliari 09133, Italy

Medical Oncology Department, Catanzaro 88100, Italy

Medical Oncology Department, Cosenza 87100, Italy

Medical Oncology Department, Cremona 26100, Italy

Medical Oncology Department, Ferrara 44100, Italy

Medical Oncology Department Careggi Hospital, Firenze 50139, Italy

Cancer institute of Romagna, Forlì 47100, Italy

Medical Oncology Department, Latina 04100, Italy

Medical Oncology Department, Lecce 73100, Italy

Medical Oncology Department, Lucca 55100, Italy

Gynecology Oncology INT, Milano 20133, Italy

Medical Oncology Department Fatebenefratelli Hospital, Milano 20121, Italy

Medical Oncology Department Policlinico, Milano 20122, Italy

Medical Oncology Department San Carlo Hospital, Milano 20153, Italy

University Bicocca, Milano 20052, Italy

Medical Oncology Department Istituto Oncologico Veneto, Padova 35128, Italy

Medical Oncology Department, Palermo 90127, Italy

Salvatore Maugeri Foundation, Pavia 27100, Italy

Medical Oncology Department, Perugia 06156, Italy

Hematology and Oncology Department, Piacenza 29100, Italy

Medical Oncology Department - University of Pisa, Pisa 56126, Italy

Medical Oncology Department, Ravenna 48100, Italy

Medical Oncology Department, Reggio Emilia 42100, Italy

Medical Oncology Department - S Filippo Hospital, Roma 00135, Italy

Medical Oncology Department Regina Elena Institute, Roma 00144, Italy

Medical Oncology Department 3 Regina Elena Cancer Institute, Rome 00144, Italy

Onco-gynecology Department - Catholic University, Rome 00168, Italy

Medical Oncology Department, Sassari 07100, Italy

Medical Oncology Department, Terni 05100, Italy

Oncology Department Molinette Hospital, Torino 10126, Italy

Medical Oncology Department, Varese 21100, Italy

Medical Oncology Department, Viterbo 01100, Italy

Medical Oncology Department, Fabriano, Ancona 60044, Italy

Medical Oncology Department, Treviglio, Bergamo 24047, Italy

Casa Sollievo dell Sofferenza, San Giovanni Rotondo, Foggia 71013, Italy

Medical Oncology Department, Taormina, Messina 98039, Italy

Medical Oncology Department, Legnano, Milano 20025, Italy

Istituto Clinico Humanitas, Rozzano, Milano 20089, Italy

Medical Oncology Department, Camposampiero, Padova 35012, Italy

Medical Oncology Department, CittĂ  di Castello, Perugia 06012, Italy

Medical Oncology Department, Todi, Perugia 06059, Italy

Medical Oncology Department San Luigi Hospital, Orbassano, Torino 10043, Italy

Additional Information

Starting date: October 2003
Last updated: January 31, 2012

Page last updated: August 20, 2015

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